Day 1 - ET (Eastern Time, GMT-05:00)
Day 1 - ET (Eastern Time, GMT-05:00)
- Discuss the latest on the recently implemented USP 797 and anticipated impact on sterile compounding
- Updates on USP 795 and USP 800
- Analysis on how different states are adopting and implementing these guidance
- Lauren Pearson, Pharm.D., MBA - Senior Scientist I, Personalized Medicines, US Pharmacopeia
- Gain insight on how independent and national compounding companies can prepare for inspections
- Preparing for on-site and remote inspections
- Handling 483s once you are inspected
- Ross Caputo, PhD - President, Eagle Analytical
- Understanding the desired or required regulatory standard for your organization
- Building a stability program framework tailored around that regulatory standard
- Differences amongst types of organizations – Hospitals, 503A, or 503B
- Successful achievement of Beyond Use Dating or Expiration Dating
- Masoud Rashidi, PharmD - Chief Compounding Pharmacist, Innovative Compounding Pharmacy
- Lisa McChesney-Harris, PhD - CEO, CSO & Founder, Prompt Praxis Laboratories LLC
Gain insights on regulatory perspectives from State board representatives regarding recent regulatory updates and what to know when you are licensed in multiple states.
- Renee Barker, PharmD, BCSCP - Member, California State Board of Pharmacy
- Expectations of USP 795 for non-sterile compounding pharmacies
- Which unsanitary conditions documents are applicable to 503As
- Ted Toufas - Compounding Pharmacist, Acton Pharmacy
- Victor Hill - Directory of Quality, Vios Compounding
Explore the strategies in managing patient care amidst both drug shortages and 503B product scarcities, while gaining insights on the essential methodologies 503A compounding pharmacies can employ to effectively vet their supplies, mitigating potential risks within the supply chain.
- Viral Jani - Director of Operations, Town & Country Compounding
- Renee Barker, PharmD, BCSCP - Sterile Product Manager, Stanford Childrens Health
With the recent supply chain issues and drug shortages, discuss:
- How compounding pharmacies will be working to fill those gaps
- What 503Bs are currently doing in the interim to mitigate shortages?
- FDA considerations on bulk list revisions due to drug shortage
- Navigating drug shortages due to quality issues from 503Bs
- Aseptic process manipulation
- Shipping and validation for compounds
- Qualifying vendors for API and critical components
- 503 Bulk Lists
- Trupti Sindhi - Manager Manufacturing Operations, QuVa Pharma
- Sophia Flores - Director of Manufacturing Operations, QuVa Pharma
- Jon Kallay - Senior Technology and Market Development Manager, Charles River
- Testing requirements for sterile and non-sterile compounding
- Strategies for identifying and mitigating inconsistencies in 503A products
- Jules D'Souza - 503A Quality Director, Empower Pharmacy
- Katrina Harper - Director of Clinical Education, AIS Healthcare
- Discuss the challenges surrounding USP 800 and the yet to be revised NIOSH list
- Stay up to date with documentation requirements regarding environmental monitoring.
- Keeping up with environmental monitoring documentation requirements.
- Kathleen Kane - Assistant Director of Pharmacy, Compounding Integrity and Compounding Regulatory Compliance, UChicago Medicine
Engage in discussions on FDA 483 trends, the progression of the 503B market, and strategic measures to stay ahead of the curve in this industry
Balancing increased production with quality assurance is a key challenge for Compounding Pharmacies. Discover how a top 503B outsourcing facility achieved this by prioritizing Quality Control Risk-Based Management, implementing reliable rapid sterility testing methods like solid phase cytometry for safe product release.